Automated analyzer and determination method

Abstract

The purpose of the present invention is to provide an automated analyzer capable of improving analysis precision of blood serum. For said purpose, the present invention relates to an automated analyzer comprising: a liquid discharge mechanism that discharges a liquid into a reaction container; a photometer that acquires a luminous intensity at a time when the reaction container having accommodated therein the liquid discharged by the liquid discharge mechanism is irradiated with light; a mechanism control unit that controls the liquid discharge mechanism and the photometer; and a determination unit that determines the state of the reaction container on the basis of the luminous intensity acquired by the photometer. The determination unit determines whether or not the reaction container is contaminated with a separating agent, on the basis of a first luminous intensity acquired by the photometer when pure water is accommodated in the reaction container and a second luminous intensity acquired by the photometer when a surfactant-containing liquid is accommodated in the reaction container.

Description

Automated analyzer and determination method

[0001] The present invention relates to an automated analyzer and a determination method for determining the state of a reaction vessel used in the automated analyzer.

[0002] In an automated analyzer for biochemical analysis, generally, reaction vessels are used. If impurities adhere to or the reaction vessels are damaged, it may affect the measurement of the absorbance of the reaction solution ejected into the reaction vessels, and the accuracy of the analysis results may not be ensured. Therefore, it is required to determine the state of the reaction vessels used in the automated analyzer. For example, Patent Document 1 describes an automated analyzer provided with a multi-determination unit that determines the quality of a reaction vessel based on the immediately previous measured value and the latest measured value of the water blank absorbance of the reaction vessel.

[0003] JP 2017-32500 Gazette

[0004] When measuring serum as a sample with an automated analyzer, a process of obtaining blood collected from a patient into a blood collection tube containing a separation material and centrifuging it is performed. By the centrifugation process, the blood is separated from the bottom of the blood collection tube in order of a blood clot layer, a separation material, and a serum layer due to the difference in specific gravity of the blood components. After the centrifuged blood collection tube is directly transported into the automated analyzer, the sample in the blood collection tube is generally dispensed and used for analysis.

[0005] However, if there are deficiencies in the centrifugation of the blood collection tube or the sample volume in the blood collection tube is extremely small, when the sample is dispensed from the blood collection tube with an automated analyzer, the separation agent in the blood collection tube may adhere to the sample dispensing mechanism. If the separation agent adheres to the sample dispensing mechanism, the separation agent adhering to the sample dispensing mechanism may adhere to other mechanism parts, and as a result, if the separation agent adheres to the reaction vessel, the accuracy of the analysis results may not be ensured.

[0006] Since the automated analyzer described in Patent Document 1 determines the quality of the reaction vessel based on the absorbance when pure water is ejected into the reaction vessel, it is difficult to detect a state where the separation agent adheres to the reaction vessel.

[0007] The objective of the present invention is to provide an automated analyzer that can improve the accuracy of serum analysis.

[0008] The present invention has been made in view of the above problems, and one aspect thereof is an automatic analyzer comprising: a liquid discharge mechanism for discharging liquid into a reaction vessel; a photometer for acquiring the luminous intensity when light is irradiated onto the reaction vessel containing the liquid discharged by the liquid discharge mechanism; a mechanism control unit for controlling the liquid discharge mechanism and the photometer; and a determination unit for determining the state of the reaction vessel based on the luminous intensity acquired by the photometer, wherein the determination unit determines whether or not there is contamination of the reaction vessel with a separating agent based on a first luminous intensity acquired by the photometer when pure water is contained in the reaction vessel and a second luminous intensity acquired by the photometer when a liquid containing a surfactant is contained in the reaction vessel.

[0009] According to the present invention, it is possible to provide an automated analyzer that can improve the accuracy of serum analysis.

[0010] A perspective view showing a schematic configuration example of an automated analyzer according to an embodiment. A functional block diagram of the controller. A flowchart showing an example of the operation when determining whether or not there is contamination of the reaction vessel with a separating agent during analysis in Example 1. A screen for setting the judgment threshold for alarm output. A diagram showing the state when a fixed value is selected on the screen for setting the detergent absorbance correction value. A diagram showing the state when a measured value is selected on the screen for setting the detergent absorbance correction value. A flowchart showing an example of the operation when acquiring the detergent absorbance correction value in Example 1. A flowchart showing an example of the operation of reaction vessel contamination determination and special cleaning in Example 2. A screen for setting special cleaning. A flowchart showing an example of the operation when determining whether or not there is contamination of the reaction vessel with a separating agent in Example 3. A flowchart showing an example of the operation when it is determined that there is contamination of the reaction vessel with a separating agent in Example 4. A screen for checking the result of the separation agent contamination determination of the reaction vessel.

[0011] Embodiments of the present invention will be described in detail below with reference to the drawings.

[0012] Figure 1 is a perspective view showing a schematic configuration example of the automated analyzer according to this embodiment. As shown in Figure 1, the automated analyzer mainly comprises sample transport mechanisms 36, 37, reaction disk 1, reagent disk 9, sample dispensing mechanisms 34, 35, reagent dispensing mechanisms 7, 8, stirring mechanisms 5, 6, spectrophotometer 4, washing mechanism 3, and controller 21.

[0013] The sample transport mechanisms 36 and 37 transport a rack 16, which is loaded with multiple sample containers 15 containing samples, to a desired position. The reaction disk 1 stores multiple reaction vessels 2 (reaction cells) on its circumference at predetermined intervals from each other. The reagent disk 9 stores multiple reagent bottles 10 containing any reagent or detergent on its circumference.

[0014] The sample dispensing mechanisms 34 and 35 are installed between the reaction disk 1 and the sample transport mechanisms 36 and 37, and have sample dispensing nozzles 11a and 12a that can rotate in an arc and move vertically. A sample pump 19 is connected to the sample dispensing nozzles 11a and 12a. The sample dispensing mechanisms 34 and 35 then draw the sample from the sample container 15 and discharge (dispense) the sample into the reaction vessel 2.

[0015] The reagent dispensing mechanisms 7 and 8 are installed between the reaction disk 1 and the reagent disk 9 and have reagent dispensing nozzles 7a and 8a that can rotate in an arc and move vertically. Reagent pumps 18 are connected to the reagent dispensing nozzles 7a and 8a. The reagent dispensing mechanisms 7 and 8 then draw reagents from the reagent bottle 10 and discharge (dispense) the reagents into the reaction vessel 2.

[0016] The stirring mechanisms 5 and 6 have, for example, a stirring blade or a spatula-shaped rod (not shown) at their tip, and stir by immersing the stirring blade or spatula-shaped rod in the reaction solution, which is a mixture of the sample and reagent in the reaction vessel 2, and rotating it. However, the stirring mechanisms 5 and 6 are not limited to this method, and an ultrasonic stirring method may also be used, in which ultrasonic waves are irradiated onto the reaction solution in the reaction vessel 2 to generate a swirling flow and perform stirring.

[0017] The spectrophotometer 4 spectrally analyzes light continuously irradiated from a light source (not shown) onto the mixture of sample and reagent in the reaction vessel 2, for example, at 340 nm, 405 nm, and 450 nm, and measures the absorbance at each wavelength. In this embodiment, the spectrophotometer 4 is used to measure absorbance by spectrally analyzing and detecting transmitted light when light is continuously irradiated onto the reaction vessel 2 from a light source. However, a photometer that measures the amount of scattered light instead of transmitted light may also be used.

[0018] The cleaning mechanism 3 is connected to a cleaning pump 20 and cleans the reaction vessel 2 by sucking up the mixed liquid from the reaction vessel 2 after measurement is complete, and by discharging and sucking up pure water and detergent. Cleaning tanks 13, 14, 30, 31, and 32, 33 are installed within the operating ranges of the sample dispensing mechanisms 34, 35, reagent dispensing mechanisms 7, 8, and stirring mechanisms 5, 6, respectively. The cleaning tanks 13, 14, which are installed within the operating ranges of the sample dispensing mechanisms 34, 35, may also use a cleaning method that cleans the sample dispensing nozzles 11a, 12a by irradiating them with ultrasound, for example.

[0019] The controller 21 controls the operation of each mechanism, and stores and displays settings and measurement results.

[0020] Figure 2 is a functional block diagram of the controller. As shown in Figure 2, the controller 21 includes a storage 210, a processor 220, a memory 230, an output unit 240, and an input unit 250. The storage 210 includes a measurement result storage unit 211, a setting storage unit 212, and a judgment result storage unit 213.

[0021] In Figure 2, the functions conceptually performed by the processor 220 are shown as the mechanism control unit 231 and the determination unit 232, and the programs for realizing each function are stored in memory. The programs may be provided pre-installed in ROM or similar media, or they may be provided or distributed as files in an installable or executable format recorded on a computer-readable recording medium. Furthermore, the programs may be stored on a computer connected to a network and provided or distributed by allowing downloads via the network.

[0022] The mechanism control unit 231 controls the operation of each part, including the liquid dispensing mechanism, which includes the dispensing mechanism and the washing mechanism. The determination unit 232 determines the state of the reaction vessel 2 based on the absorbance acquired by the spectrophotometer 4.

[0023] The output unit 240 outputs the judgment result (such as an alarm or countermeasure) from the judgment unit 232, and is, for example, a display. The input unit 250 is for setting conditions such as thresholds used in the judgment by the judgment unit 232, and is, for example, a keyboard or mouse. Note that the output unit 240 and the input unit 250 may be integrated into a single unit, such as a touch panel operation display unit.

[0024] The following description assumes that the automated analyzer according to this embodiment measures serum as a sample. To obtain serum, blood is collected from the patient, placed in a blood collection tube (sample container) containing a separating agent, and then centrifuged. The blood separating agent is pre-filled at the bottom of the blood collection tube and is, for example, silicone oil or a copolymer of α-olefin and maleic acid diester.

[0025] The inventors discovered that when a liquid containing a surfactant is discharged into a reaction vessel 2 while a separating agent is adhering to the vessel, the separating agent adhering to the vessel turns white. When this phenomenon occurs, the absorbance of the reaction vessel 2 when discharging the liquid containing a surfactant is higher than when discharging pure water. On the other hand, even when pure water is discharged and the absorbance is measured while a separating agent is adhering to the reaction vessel 2, there is no significant discrepancy compared to the absorbance obtained before the separating agent adhered to the vessel. Focusing on this phenomenon, the inventors have newly discovered a method for determining whether or not a separating agent is adhering to the reaction vessel 2. In the following examples, detergent will be used as an example of the liquid containing a surfactant.

[0026] Figure 3 is a flowchart showing an example of the operation used in Example 1 to determine whether or not there is contamination of the reaction vessel with the separation agent during the analysis process.

[0027] First, once the analysis is complete (step S301), the washing mechanism 3 dispenses pure water into the reaction vessel 2 after the analysis is finished. With the reaction vessel 2 now filled with pure water, the spectrophotometer 4 receives the light irradiated onto the reaction vessel 2 from the light source and measures the pure water absorbance X1 (first luminosity) (step S302). Once the measurement of the pure water absorbance X1 is complete, the absorbance is stored in the measurement result storage unit 211, and the washing mechanism 3 aspirates the pure water from the reaction vessel 2.

[0028] Subsequently, the cleaning mechanism 3 dispenses (dispenses) detergent into the same reaction vessel 2. With the detergent contained in the reaction vessel 2, the spectrophotometer 4 receives the light irradiated onto the reaction vessel 2 from the light source and measures the detergent absorbance X2 (second luminosity) (step S303). The measured detergent absorbance X2 is stored in the measurement result storage unit 211.

[0029] Next, the determination unit 232 corrects the detergent absorbance X2 measured in step S303 using a detergent absorbance correction value determined according to the type of detergent dispensed into the reaction vessel 2. Specifically, it subtracts the detergent absorbance correction value from the detergent absorbance X2 to obtain the corrected detergent absorbance X3 (step S304). This eliminates the influence of changes in absorbance due to the components contained in the detergent itself over time, improving the accuracy of determining the state of the reaction vessel 2.

[0030] Subsequently, the determination unit 232 determines whether the value obtained by subtracting the pure water absorbance X1 from the detergent-corrected absorbance X3 (X3-X1) is less than or equal to the first determination value (step S305). If the value of (X3-X1) is determined to be less than or equal to the first determination value, the determination unit 232 determines that there is no separation agent contamination (step S306).

[0031] On the other hand, in step S305, if it is determined that the (X3 - X1) value exceeds the first determination value, the determination unit 232 determines that there is separation agent contamination and outputs an alarm to the output unit 240 indicating that there is separation agent contamination, along with the identification number of the target reaction vessel 2 (step S307). At this time, the mechanism control unit 231 controls the cleaning mechanism 3 and the like so that the target reaction vessel 2 is not used for subsequent analysis (step S308).

[0032] Furthermore, the determination unit 232 determines whether the cumulative number of reaction vessels 2 determined to be contaminated with the separating agent is below a first threshold (step S309). If it is determined that the cumulative number exceeds the first threshold, the output unit 240 outputs an alarm prompting the replacement of the reaction vessels 2, as the number of usable reaction vessels 2 may decrease and the analysis processing capacity may be reduced (step S310).

[0033] On the other hand, in step S309, if the cumulative number is determined to be below the first threshold, the determination unit 232 determines whether the cumulative number of reaction vessels 2 determined to be contaminated with the separating agent is below the second threshold within a certain period (step S311). The certain period is, for example, the period from the completion of analysis of one reaction vessel 2 until the completion of analysis of a total of 10 reaction vessels 2, specifically 45 seconds. If the cumulative number is determined to exceed the second threshold within a certain period, it is determined that the sample dispensing mechanisms 34, 35 and the washing mechanism 3 are contaminated with the separating agent, and that the contamination may have spread to reaction vessels 2 that were not contaminated. Therefore, in this case, the mechanism control unit 231 stops the sample dispensing operation by the sample dispensing mechanisms 34, 35, and the output unit 240 outputs an alarm that indicates an abnormality in the sample dispensing mechanisms 34, 35 and prompts the user to check their status (step S312).

[0034] In addition, in steps S302 and S303 described above, the washing mechanism 3 dispensed pure water and detergent to the reaction vessel 2, but instead of the washing mechanism 3, the reagent dispensing mechanisms 7 and 8 may dispense pure water or detergent. Since the reagent disk 9 can accommodate a large number of reagent bottles 10 containing detergents of various types and concentrations, the reagent dispensing mechanisms 7 and 8 can further improve the accuracy of determining contamination of the separation agent by appropriately selecting a detergent that shows a significant change in the separation agent.

[0035] Furthermore, although the aforementioned determination flow was performed during the analysis operation of the automated analyzer, it may also be performed, for example, during maintenance of the automated analyzer or when the power is started up. In addition, to improve the accuracy of the determination of separation agent contamination, it is desirable to use absorbance at a short wavelength of 500 nm or less, such as 340 nm, which can be obtained by the automated analyzer and is easily scattered, but absorbance at other wavelengths that can be obtained by the automated analyzer may also be used.

[0036] Figures 4A, 4B, and 4C show examples of setting screens for determining separation agent contamination in a reaction vessel. Each setting screen consists of a setting item selection unit 401 for selecting setting items and a condition setting unit 402 for setting the conditions under which the settings are applied. In each setting screen, the user uses an input unit 250 to select setting items or set conditions.

[0037] Figure 4A is a screen for setting the judgment threshold for alarm output, and is displayed on the output unit 240 when the "Alarm Output" item is selected in the setting item selection unit 401. The condition setting unit 402 on this screen includes a first threshold input field 411 for inputting a threshold (first threshold) that serves as the criterion for determining whether or not to output an alarm prompting the replacement of the reaction vessel 2, and a second threshold input field 412 for inputting a threshold (second threshold) that serves as the criterion for determining whether or not to output an alarm indicating an abnormality in the sample dispensing mechanism. As shown in Figure 4A, if, for example, "15" is entered in the first threshold input field 411, the output unit 240 outputs an alarm prompting the replacement of the reaction vessel 2 when the cumulative number of reaction vessels 2 determined to have separation agent contamination exceeds 15. Also, as shown in Figure 4A, if, for example, "3" is entered in the second threshold input field 412, the output unit 240 outputs an alarm prompting the confirmation of an abnormality in the sample dispensing mechanisms 34 and 35 when the cumulative number of reaction vessels 2 determined to have separation agent contamination exceeds 3 within a certain period. In Figure 4A, the threshold value entered by the user is stored in the setting storage unit 212 of the controller 21.

[0038] Figures 4B and 4C show the screen for setting the detergent absorbance correction value, which is displayed on the output unit 240 when the "detergent absorbance correction value" item is selected in the setting item selection unit 401. The condition setting unit 402 of these screens includes a correction value selection field 421 for selecting whether the detergent absorbance correction value is a fixed value or an actual measured value, a placement location selection field 422 for selecting the placement locations of the multiple reagent bottles 10 containing the detergent on the reagent disk 9, a correction value input field 423 for inputting the detergent absorbance correction value, and a maximum allowable absorbance correction value input field 424 for inputting the maximum allowable absorbance correction value. For example, if the reagent bottles 10 are placed on Pos "60" and Pos "58" on the reagent disk 9, 60 and 58 are selected in the placement location selection field 422. The "Detergent 1" and "Detergent 2" displayed in the condition setting unit 402 indicate the types of detergents discharged from the cleaning mechanism 3 to the reaction vessel 2, but the types of detergents discharged from the cleaning mechanism 3 are not limited to these two. Furthermore, if information such as the name and expiration date of the detergents placed on the reagent disk 9 can be managed using one-dimensional codes or two-dimensional codes, the name of the detergent may be displayed in the condition setting unit 402 to make it easier for the user to select.

[0039] Figure 4B shows the screen for setting the detergent absorbance correction value, with a fixed value selected. When a fixed value is selected in the correction value selection field 421, the detergent absorbance correction value of the detergent discharged from the washing mechanism 3 and the detergent absorbance correction value of the detergent discharged (dispensed) from the reagent bottle 10 placed on the reagent disk 9 using the reagent dispensing mechanisms 7 and 8 become inputtable in the correction value input field 423. The detergent absorbance correction value entered by the user in Figure 4B is stored in the setting storage unit 212 of the controller 21. When a fixed value is selected, detergent discharge operations and other actions required to measure the detergent absorbance correction value are unnecessary, which not only saves time required to measure the detergent absorbance correction value but also has the advantage of reducing detergent consumption.

[0040] Figure 4C shows a state where the measured value is selected on the screen for setting the detergent absorbance correction value. The maximum allowable absorbance correction value entered in the maximum allowable absorbance correction value input field 424 is used in the flow for obtaining the detergent absorbance correction value shown in FIG. 5 described later. The detergent absorbance correction value of the detergent discharged from the cleaning mechanism 3 and the detergent absorbance correction value of the detergent discharged (dispensed) from the reagent bottle 10 placed on the reagent disk 9 using the reagent dispensing mechanisms 7 and 8 are measured by the operation described in FIG. 5 described later and stored in the setting storage unit 212 of the controller 21. When the measured value is selected, even if the absorbance changes over time due to deterioration of the detergent, the influence can be eliminated, and the determination accuracy of the separator stain can be kept high.

[0041] FIG. 5 is a flowchart showing an example of the operation for obtaining the detergent absorbance correction value in the first embodiment.

[0042] First, immediately after the start of analysis (step S501), the determination unit 232 determines whether the setting of the detergent absorbance correction value is the measured value (step S502). If the setting of the detergent absorbance correction value is a fixed value, the determination unit 232 obtains each detergent absorbance correction value input by the user from the setting storage unit 212 (step S503).

[0043] On the other hand, in step S502, if the setting of the detergent absorbance correction value is the measured value, the cleaning mechanism 3 discharges (dispenses) pure water into the reaction vessel 2, and in a state where the reaction vessel 2 contains pure water, the spectrophotometer 4 receives the light irradiated from the light source to the reaction vessel 2 and measures the absorbance A1 of the pure water for correction (step S504). When the measurement of the absorbance A1 of the pure water for correction is completed, the cleaning mechanism 3 sucks the pure water in the reaction vessel 2 (step S505).

[0044] Thereafter, the cleaning mechanism 3 discharges (dispenses) the detergent into the same reaction vessel 2, and in a state where the reaction vessel 2 contains the detergent, the spectrophotometer 4 receives the light irradiated from the light source to the reaction vessel 2 and measures the absorbance A2 of the detergent for correction (step S506).

[0045] Next, the determination unit 232 determines whether the value obtained by subtracting the absorbance A1 of the pure water for correction from the absorbance A2 of the detergent for correction (A2 - A1) is less than or equal to the maximum allowable absorbance correction value (step S507). If it is determined that the value (A2 - A1) exceeds the maximum allowable absorbance correction value, there may be an abnormal detergent absorbance correction value due to impurities in the reaction vessel 2 or scratches on the reaction vessel 2. Therefore, the processes after step S504 are executed again using another reaction vessel 2 (step S508).

[0046] On the other hand, in step S507, if it is determined that the value (A2 - A1) is less than or equal to the maximum allowable absorbance correction value, the determination unit 232 acquires the value (A2 - A1) as the detergent absorbance correction value (step S509).

[0047] Next, the determination unit 232 determines whether the detergent absorbance correction value has been acquired for all the detergents set on the screen of FIG. 4C (step S510). If there is a detergent for which the detergent absorbance correction value has not been acquired, the flow after step S504 is executed again to acquire the detergent absorbance correction value for the next detergent (S511). When the acquisition of the detergent absorbance correction value is completed for all the detergents, the analysis is started.

[0048] In steps S504 and S506 described above, the cleaning mechanism 3 discharges (dispenses) pure water and detergent to the reaction vessel 2. However, instead of the cleaning mechanism 3, the reagent dispensing mechanisms 7 and 8 may discharge (dispense) pure water or detergent. Further, the operation of FIG. 5 may be executed at an arbitrary timing, not limited to immediately after the start of analysis, such as at the time of device startup or when returning from the sleep state.

[0049] In this embodiment, basically, the determination shown in FIG. 3 is executed at the timing of the cleaning operation for the reaction vessel 2 after the analysis is completed. Therefore, it is possible to determine whether there is contamination of the separating agent in the reaction vessel 2 without adding unnecessary steps. Also, regardless of whether a fixed value or a measured value is selected as the detergent absorbance correction value, it is possible to accurately determine the presence or absence of contamination of the separating agent in the reaction vessel 2, thus ensuring the analysis accuracy of the serum.

[0050] Example 2 is an example of performing a special cleaning on reaction vessel 2 when it is determined that the reaction vessel 2 is contaminated with a separating agent.

[0051] Figure 6 is a flowchart showing an example of the reaction vessel contamination detection and special cleaning operation in Example 2. The operation of steps S601 to S606 in Figure 6 is the same as the operation of steps S301 to S306 in Figure 3, so the explanation is omitted.

[0052] In step S605, if it is determined that the (X3 - X1) value exceeds the first determination value, the determination unit 232 determines that there is separation agent contamination and outputs an alarm to the output unit 240 indicating that there is separation agent contamination (step S607).

[0053] Subsequently, the determination unit 232 determines whether the (X3 - X1) value is less than or equal to a second determination value which is greater than the first determination value (step S608). If it is determined that the (X3 - X1) value exceeds the second determination value, the determination unit 232 determines that there is severe separation agent contamination in the reaction vessel 2 (step S609). In this case, the mechanism control unit 231 stops the cleaning operation by the cleaning mechanism 3 on the reaction vessel 2 and controls each mechanism so that the reaction vessel 2 is not used for analysis (step S610).

[0054] On the other hand, in step S608, if the (X3 - X1) value is determined to be less than or equal to the second determination value, the determination unit 232 determines that there is slight contamination of the reaction vessel 2 with the separating agent (step S611). In this case, the mechanism control unit 231 performs a special cleaning on the reaction vessel 2 that is different from the normal cleaning performed on the reaction vessel 2 after the analysis has been completed (step S612). In the special cleaning, for example, the reagent dispensing mechanisms 7 and 8 draw up detergent for special cleaning from the reagent bottles 10 placed on the reagent disc 9 and discharge it into the reaction vessel 2, after which the stirring mechanisms 5 and 6 stir the solution in the reaction vessel 2.

[0055] Subsequently, the processes from step S302 onward in Figure 3 are performed (step S613), and if it is determined that the reaction vessel 2 is free of separation agent contamination, the reaction vessel 2 is used for subsequent analyses. Furthermore, if the automated analyzer has a function to clean the sample dispensing nozzles 11a and 12a by irradiating them with ultrasonic waves from cleaning tanks 13 and 14 located within the operating range of the sample dispensing mechanisms 11 and 12, the sample dispensing nozzles 11a and 12a are cleaned in these cleaning tanks.

[0056] Figure 7 is a screen for setting special cleaning, and is displayed on the output unit 240 when the "Special Cleaning" item is selected in the setting item selection unit 401. The condition setting unit 402 on this screen includes a checkbox 711 for selecting whether or not special cleaning is required for the reaction vessel 2, and an input field 712 for selecting the location of the reagent disc 9 on the reagent bottle 10 that contains the cleaning agent used for special cleaning. If the checkbox 711 is set to ON, special cleaning is performed in step S612 in Figure 6. On the other hand, if the checkbox 711 is set to OFF, special cleaning is not performed, and the mechanisms are controlled so that the reaction vessel 2 is not used for analysis thereafter. The information selected by the user in Figure 7 is stored in the setting storage unit 212 of the controller 21.

[0057] In this embodiment, if a detergent that has a cleaning effect on separation agent contamination is available and the user has pre-set the special cleaning setting using that detergent to ON, it may be possible to reuse the reaction vessel 2 that has been determined to have separation agent contamination for analysis. As a result, not only can the frequency of replacing the reaction vessel 2 be reduced, but a decrease in the processing capacity of the analysis can also be prevented.

[0058] Example 3 is an example of reducing false positives in the determination by determining the presence of the separation agent in the reaction vessel 2 based on absorbance measured at multiple timings.

[0059] Figure 8 is a flowchart showing an example of the operation in Example 3 for determining whether or not there is contamination of the reaction vessel with the separating agent. The operation of steps S801 to S806 in Figure 8 is the same as the operation of steps S301 to S306 in Figure 3, so the explanation is omitted. Here, we will explain the subsequent operation when it is determined in step S805 of Figure 8 that the (X3 - X1) value exceeds the first determination value.

[0060] In this case, the washing mechanism 3 again dispenses (dispenses) pure water into the reaction vessel 2 to be judged, and with the reaction vessel 2 containing pure water, the spectrophotometer 4 receives the light irradiated onto the reaction vessel 2 from the light source and measures the pure water absorbance X4 (third luminosity) (step S807). The measured pure water absorbance X4 is stored in the measurement result storage unit 211.

[0061] Next, the determination unit 232 determines whether the value obtained by subtracting the pure water absorbance X1 from the pure water absorbance X4 (X4-X1) is less than or equal to the third determination value (false positive determination value for reaction vessel separation agent contamination) (step S808). If the determination unit 232 determines that the value of (X4-X1) exceeds the third determination value, the determination unit 232 determines that the reaction vessel 2 is contaminated with separation agent, and the operations from step S308 onwards in Figure 3 are executed (step S809).

[0062] On the other hand, if in step S808 the (X4 - X1) value is determined to be less than or equal to the third determination value, it is determined that there is no separation agent contamination in the reaction vessel 2 (step S806).

[0063] Thus, in this embodiment, when it is determined that reaction vessel 2 may be contaminated with a separating agent, the system re-evaluates whether or not this is correct. The reason for this is explained below.

[0064] Even if separation agent contamination does not actually occur in reaction vessel 2, if there are bubbles or impurities in reaction vessel 2, the measurement result of the detergent absorbance X2 will be high due to their influence, and it is possible that the (X3-X1) value will be judged to exceed the first judgment value in step S805. Here, in reaction vessel 2 where separation agent actually adheres, the separation agent turns white when the detergent is discharged, so when pure water is discharged in step S807 and the pure water absorbance X4 is measured, a discrepancy will occur with the pure water absorbance X1 measured in step S802. However, in reaction vessel 2 where separation agent contamination does not adhere, the detergent does not turn white when the detergent is discharged, so when pure water is discharged in step S807 and the pure water absorbance X4 is measured, no discrepancy will occur with the pure water absorbance X1 measured in step S802. Thus, even if the (X3-X1) value exceeds the first judgment value, if the discrepancy between the pure water absorbance X4 and the pure water absorbance X1 is small, it can be determined that there is no separation agent contamination, thereby suppressing a decrease in the analytical processing capacity.

[0065] Example 4 is an example in which the factors causing separation agent contamination are made easier to evaluate by looking at the changes in reaction vessel 2, which is determined to have separation agent contamination, and sample information.

[0066] Figure 9 is a flowchart showing an example of the operation when separation agent contamination is determined to be present in the reaction vessel in Example 4. The operation prior to step S901 in Figure 9 is the same as the operation in steps S301 to S305 in Figure 3. Here, we will explain the subsequent operation when the (X3 - X1) value is determined to exceed the first determination value in step S305 of Figure 3.

[0067] In this case, the output unit 240 outputs an alarm indicating that the reaction vessel 2 is contaminated with the separating agent (step S902). At this time, the output unit 240 also outputs information such as the management numbers of multiple samples previously dispensed to the target reaction vessel 2 (for example, 10 samples dispensed immediately before the determination) within the alarm (step S903). The sample management numbers are, for example, the management code written on the blood collection tube body or the identification number written on the rack 16. Since information such as the sample management numbers is also output in this way, the user can trace the samples dispensed into the reaction vessel 2 that has been determined to be contaminated with the separating agent. As a result, it becomes possible to identify multiple sample containers 15 that may have caused the separating agent to adhere to the sample dispensing nozzles 11a and 12a, and prompts the user to check whether the sample containers 15 are properly mounted on the rack 16 and whether there are any abnormalities in the sample containers 15.

[0068] Furthermore, the mechanism control unit 231 controls the cleaning mechanism 3 and other components so that the target reaction vessel 2 is not used for subsequent analyses (step S904).

[0069] Steps S905 and S907 in Figure 9 are the same as steps S309 and S310 in Figure 3.

[0070] In step S907, after the output unit 240 outputs a reaction vessel replacement recommendation alarm, the determination unit 232 obtains from the determination result storage unit 213 the number of days from the last replacement date and time of the reaction vessel 2 until the reaction vessel replacement recommendation alarm is output (the period until the cumulative number of reaction vessels determined to have separation agent contamination exceeds the first threshold) (step S908).

[0071] Next, the determination unit 232 determines whether the period acquired in step S908 is shorter than a certain amount compared to the past (for example, whether it is less than 70% of the previous value) (step S909). If it is determined that the period is shorter than a certain amount compared to the past, the output unit 240 outputs an alarm prompting the user to check the sample container or sample, as there may be a problem with the condition of the blood collection tube or the sample preprocessing.

[0072] On the other hand, if it is determined in step S909 that the length has not decreased by a certain amount compared to the past, the operations from step S311 onwards in Figure 3 are executed (step S906).

[0073] Figure 10 is a screen for checking the results of the separation agent contamination judgment of the reaction vessel, and is displayed on the output unit 240 when a predetermined operation is performed by the input unit 250. As shown in Figure 10, the screen displays the last replacement date 1011 of the reaction vessel 2, the cumulative number of reaction vessels 2 that have been contaminated with separation agent 1012, and a graph 1013 showing the trend of the cumulative number of reaction vessels 2 that have been contaminated with separation agent. The information displayed on this screen is stored in the judgment result storage unit 213 of the controller 21. By checking this screen, the user can easily check the trend of the cumulative number of reaction vessels 2 that have been contaminated with separation agent from the last replacement date to the present. For example, if separation agent contamination of the reaction vessel 2 is significantly occurring on a particular date, it is possible to infer that there were conditions that made separation agent contamination likely to occur in the work performed on that date (such as sample pretreatment).

[0074] The present invention is not limited to the embodiments described above, and various modifications are possible. Furthermore, it is possible to replace parts of the configuration of each embodiment with those of other embodiments. It is also possible to add configurations from other embodiments to the configuration of each embodiment. Additionally, it is possible to add, delete, or replace parts of the configuration of each embodiment with those of other embodiments.

[0075] 2...Reaction vessel, 3...Washing mechanism, 4...Spectrophotometer, 5, 6...Stirring mechanism, 7, 8...Reagent dispensing mechanism, 7a, 8a...Reagent dispensing nozzle, 9...Reagent disc, 10...Reagent bottle, 11a, 12a...Sample dispensing nozzle, 13, 14, 30, 31, 32, 33...Washing tank, 15...Sample container, 16...Rack, 19...Sample pump, 21...Controller, 34, 35...Sample dispensing mechanism, 36, 37... Sample transport mechanism, 401... Setting item selection unit, 402... Condition setting unit, 411... First threshold input field, 412... Second threshold input field, 421... Correction value selection field, 422... Placement location selection field, 423... Correction value input field, 424... Maximum allowable absorbance correction value input field, 711... Checkbox, 712... Input field, 1011... Last replacement date, 1012... Cumulative count, 1013... Graph

Claims

1. An automatic analyzer comprising: a liquid discharge mechanism for discharging liquid into a reaction vessel; a photometer for acquiring the luminosity when light is irradiated onto the reaction vessel containing the liquid discharged by the liquid discharge mechanism; a mechanism control unit for controlling the liquid discharge mechanism and the photometer; and a determination unit for determining the state of the reaction vessel based on the luminosity acquired by the photometer, wherein the determination unit determines whether or not there is contamination of the reaction vessel with a separating agent based on a first luminosity acquired by the photometer when pure water is contained in the reaction vessel and a second luminosity acquired by the photometer when a liquid containing a surfactant is contained in the reaction vessel.

2. An automatic analyzer according to claim 1, characterized in that, when it is determined that the reaction vessel is contaminated with the separating agent, the mechanism control unit controls the liquid discharge mechanism so as not to use the reaction vessel for analysis.

3. An automatic analyzer according to claim 1, wherein the liquid discharge mechanism is a cleaning mechanism for cleaning the reaction vessel after analysis has been completed, and the photometer acquires the first photometric and the second photometric during the cleaning operation of the reaction vessel.

4. An automated analyzer according to claim 1, wherein the second luminosity is corrected by a correction value to eliminate the influence of the luminosity originating from the surfactant-containing liquid itself, and the determination unit determines that the reaction vessel is contaminated with the separating agent if the difference between the corrected second luminosity and the first luminosity exceeds a first determination value.

5. An automatic analyzer according to claim 4, further comprising an input unit for selecting whether the correction value is a measured value or a fixed value.

6. An automatic analyzer according to claim 4, wherein the determination unit determines whether the difference between the corrected second luminosity and the first luminosity exceeds a second determination value greater than the first determination value, and if it is determined that the difference between the corrected second luminosity and the first luminosity does not exceed the second determination value, the mechanism control unit performs a cleaning different from the cleaning of the reaction vessel after the analysis has been completed.

7. An automated analyzer according to claim 4, wherein the photometer acquires a third photometer even after acquiring the first and second photometers while pure water is contained in the reaction vessel, and the determination unit determines that there is no contamination of the separation agent in the reaction vessel if the difference between the third photometer and the first photometer is less than or equal to a third determination value.

8. An automatic analyzer according to claim 1, further comprising an output unit that outputs the determination result from the determination unit, wherein the determination unit determines whether the cumulative number of reaction vessels determined to be contaminated with the separating agent exceeds a first threshold, and if the cumulative number is determined to exceed the first threshold, the output unit outputs an alarm prompting the replacement of the reaction vessel.

9. An automatic analyzer according to claim 1, further comprising an output unit for outputting the determination result from the determination unit, wherein the determination unit determines whether the cumulative number of reaction vessels determined to be contaminated with the separating agent exceeds a second threshold within a certain period of time, and if the cumulative number is determined to exceed the second threshold within a certain period of time, the output unit outputs an alarm indicating an abnormality in the sample dispensing mechanism that dispenses the sample into the reaction vessel.

10. An automatic analyzer according to claim 1, further comprising an output unit that outputs a statement to the effect that the reaction vessel is contaminated with the separating agent, wherein the output unit outputs information of samples previously discharged to the reaction vessel that has been determined to be contaminated with the separating agent.

11. An automatic analyzer according to claim 8, characterized in that, if the period until the cumulative count exceeds the first threshold is shorter than a certain amount compared to the past, the output unit outputs an alarm prompting confirmation of the sample container or sample.

12. An automatic analyzer according to claim 1, further comprising an output unit that graphically displays the cumulative number of reaction vessels in which contamination of the separating agent is determined to be present.

13. A determination method for determining the state of a reaction vessel used in an automated analyzer, characterized in that it determines whether or not there is contamination of the reaction vessel with a separating agent based on a first photometric value obtained by a photometer when pure water is contained in the reaction vessel and a second photometric value obtained by the photometer when a liquid containing a surfactant is contained in the reaction vessel.

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